What cancer patients need to know about clinical trials

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The Question: I have run out of conventional medical treatments for my cancer, which has metastasized. How do I join a clinical trial? How do I increase my chances of receiving the drug rather than taking a sugar pill?

The Answer: For this question – a common one here at Sunnybrook’s Odette Cancer Centre – I went to Scott Berry, who in addition to being a medical oncologist is also a bioethicist.

“As an oncologist, we have made great advances in improving outcomes for people with cancer but we need to do better. The best way of doing this is to study new treatments so we put a high priority on offering our patients the chance to take part in a clinical trial,” Dr. Berry said in an interview in the cancer center, the second largest in Canada.

Currently there are more than 650 clinical trials taking place across Canada for all different forms of cancers.

Trials aren’t always for patients who have run out of conventional treatments. And most are not placebo controlled so the worries over a sugar pill are few. Most trials today compare a new treatment to a current one.

More broadly, a trial is an intervention that can be a drug, surgery, device, radiation, diet or even an exercise program. The results can be compared to a new medical approach, a standard one already available or a placebo. It can even be compared to nothing at all. The purpose is medical knowledge.

For some patients who have exhausted other conventional therapies, a clinical trial can be seen as a lifesaver. Doctors always try to give patients the full picture: that as much as this may lengthen their lives or reduce their symptoms, it doesn’t work in every patient every time.

“We have to balance this hope and encourage people. But we have to remind them that although we hope that people getting the new treatment will do better, in some cases, they could do worse,” said Dr. Berry. “And unless we do this type of study we will never know for sure.”

Indeed, a dozen years ago, there was little oncologists could provide to patients whose colorectal cancer had spread. Back then patients faced an average life expectancy of one year. Now, there are five new drugs available and many patients live twice as long.

Clinical trials can last months or years as researchers try to determine the safety of a given intervention and, whether it helps, harms or is no different than what is currently provided. Certain outcomes are measured in patients, often to the current available treatment.

A significant issue for patients and clinicians is informed consent, said Dr. Berry, who is also a bioethicist.

“We tell them why we are doing the trial, the background information, but we do not promise too much,” he said.

“I think the thing is we hope things will be better but we really don’t know that.”

Some patients want to sign up right away after hearing details, going over the risks with the oncologists or nurses, but Dr. Berry always tells them to sleep on it. Most come back, wanting to discuss options.

“Some are uncomfortable with the randomness of it,” said Dr. Berry.

There are four phases to clinical trials, with phase 1 being the earliest, smallest – recruiting up to about 30 patients – and are often referred to as dosing or safety trials.

Phase 2 trials try to find out what types of cancer the drugs work for and to get a better idea of side effects.

If it works well, it goes onto Phase 3 trials, which are large trials [hundreds or thousands of patients recruited at many centres] that compare a new treatment with the standard one, different doses or ways of giving a standard treatment. These trials are randomized, which means that patients are put into two groups: one to get the new treatment and the other to get the standard or placebo [a sugar pill if there is no standard treatment. That type of study is the gold standard for establishing new treatments.

“We are very clear about the [treatment] goals,” he said. “There are enthusiastic people who want something done but they have to be willing to understand what the goals are.”

Even if a clinical trial is not available at your hospital, it could be elsewhere, such as other teaching or community hospitals.

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2 Comments

Andreas Laupacis

December 6, 2012 at 8:54 AM

Hi Lisa. Great blog. One thing that I think is missing is the role of patients in determining what kind of research is done and in the design of those studies. In Canada, I think we lag well behind other countries in this regarding, particularly the UK.

Their National Health Service supports a group called Involve (http://www.invo.org.uk/) which supports greater patient involvement in research. In May I visited Involve and met some people who were patients with cancer or cancer survivors. They told me how they had input into the choice of the research that is done (for example, many patients had problems with post-treatment fatigue but little research had been done on the best ways of treating it), the evaluation of the study protocol (in particular how to increase the likelihood that patients would be keen to participate in a trial), and making patients aware of trials. They showed me a map of England posted on their wall which showed the proportion of cancer patients in each region who were enrolled in trails, and said they felt the patients in areas where enrollment was low were being denied an essential aspect of health care – the right to participate in research to try to improve care. They were real advocates for research.

Another important reason to involve patients is to make sure that the information provided to them is understandable. I clicked on the link to Canadian Cancer Trials that is at the bottom of your article and went to the section on prostate cancer. Unfortunately, the titles of the trials provided are likely to be incomprehensible to the vast majority of patients. One title is "Prostate radiation therapy or short term androgen deprivation therapy and pelvic lymph node radiation therapy with of without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer."

Wow! A title on the other extreme is "CTC Pros". I applaud the Canadian Cancer Society for developing a site that provides patients with information about the trials available to them, but it would be great if there was an attempt to make the description of the trials understandable to most people.

Andreas,
Nice to hear from you. And fascinating comments on how the UK incorporates patients. I knew they included the patient voice but did not realize how far it reached into clinical trials and how they were able to point on a map to show patient involvement. What is it like here for cancer treatment? I do think you are correct about the titles – especially the one you pointed out. Plain language works best, especially for an area so filled with complex terms.

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This document is provided under the terms of a CreativeCommons Attribution Non-commercial Share Alike license. The terms of the license are available at: http://creativecommons.org/licenses/by-nc-sa/3.0/. Attributions are to be made to HealthyDebate.ca, a project under the direction of Dr. Andreas Laupacis, at the Keenan Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital.